Multicenter study to transplant hepatitis C-infected kidneys (mythic): An open-label study of combined glecaprevir and pibrentasvir to treat recipients of transplanted kidneys from deceased donors with hepatitis c virus infection

Meghan E. Sise, David S. Goldberg, Jens J. Kort, Douglas E. Schaubel, Rita R. Alloway, Christine M. Durand, Robert J. Fontana, Robert S. Brown, John J. Friedewald, Stacey Prenner, J. Richard Landis, Melissa Fernando, Caitlin C. Phillips, E. Steve Woodle, Adele Rike-Shields, Kenneth E. Sherman, Nahel Elias, Winfred W. Williams, Jenna L. Gustafson, Niraj M. DesaiBrittany Barnaba, Silas P. Norman, Mona Doshi, Samuel T. Sultan, Meredith J. Aull, Josh Levitsky, Dianne S. Belshe, Raymond T. Chung*, Peter P. Reese

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

Abstract

Background Single-center trials and retrospective case series have reported promising outcomes using kidneys from donors with hepatitis C virus (HCV) infection. However, multicenter trials are needed to determine if those findings are generalizable. Methods We conducted a prospective trial at seven centers to transplant 30 kidneys from deceased donors with HCV viremia into HCV-uninfected recipients, followed by 8 weeks of once-daily coformulated glecaprevir and pibrentasvir, targeted to start 3 days posttransplant. Key outcomes included sustained virologic response (undetectable HCV RNA 12 weeks after completing treatment with glecaprevir and pibrentasvir), adverse events, and allograft function. Results We screened 76 patients and enrolled 63 patients, of whom 30 underwent kidney transplantation from an HCV-viremic deceased donor (median kidney donor profile index, 53%) in May 2019 through October 2019. The median time between consent and transplantation of a kidney from an HCV-viremic donor was 6.3 weeks. All 30 recipients achieved a sustained virologic response. One recipient died of complications of sepsis 4 months after achieving a sustained virologic response. No severe adverse events in any patient were deemed likely related to HCV infection or treatment with glecaprevir and pibrentasvir. Three recipients developed acute cellular rejection, which was borderline in one case. Three recipients developed polyomavirus (BK) viremia near or.10,000 copies/ml that resolved after reduction of immunosuppression. All recipients had good allograft function, with a median creatinine of 1.2 mg/dl and median eGFR of 57 ml/min per 1.73 m2 at 6 months. Conclusions Our multicenter trial demonstrated safety and efficacy of transplantation of 30 HCV-viremic kidneys into HCV-negative recipients, followed by early initiation of an 8-week regimen of glecaprevir and pibrentasvir.

Original languageEnglish (US)
Pages (from-to)2678-2687
Number of pages10
JournalJournal of the American Society of Nephrology
Volume31
Issue number11
DOIs
StatePublished - Nov 2020

ASJC Scopus subject areas

  • Nephrology

Fingerprint

Dive into the research topics of 'Multicenter study to transplant hepatitis C-infected kidneys (mythic): An open-label study of combined glecaprevir and pibrentasvir to treat recipients of transplanted kidneys from deceased donors with hepatitis c virus infection'. Together they form a unique fingerprint.

Cite this